284 JOURNAL OF THE SOCIETY OF COSMETIC CHEMISTS MATERIALS AND METHODS (Bristol-Myers) I. TEST POPULATION The subjects utilized in this test were drawn from a population of healthy volunteers, 18 years of age or older. These subjects were able to develop a moderate axillary odor and had no medical history of allergy to deodorants and/or antiperspirants. II. TEST MATERIALS A. Products Evaluated 1. In Study # 1, an unscented, aluminum salt antiperspirant emulsion was compared with a placebo containing water instead of the aluminum salt. 2. In Study #2, a scented, aluminum salt antiperspirant emulsion was compared with a scented placebo containing water instead of the aluminum salt. 3. In Study #3, two unscented aluminum salt antiperspirant aerosol formulas were compared. Both were in silicone-based vehicles but contained different excipients. B. Product Application The axillae were washed with tepid water and Ivory soap with a gauze pad, followed by a water rinse to remove excess soap, and then dried with a paper towel just prior to each application. The products used in these studies were applied as follows: Lotions. Approximately 300 mg of product were applied to each axilla and swabbed into the entire axillary vault with the side of a 1-cc tuberculin syringe. A new syringe was used for each panelist. Aerosols. Subjects were treated with a direct two-second spray at a distance of approx- imately six inches from the axillary vault. A new container was used each day. A random test pattern was employed. Half the panel had one material applied to the left axilla and the other material to the right axilla, while the remaining panelists had the reverse product axilla allocation. III. DETAILED METHODOLOGY A. Subject Selection When possible, subjects were prescreened to assure the capability of developing a moderate axillary odor (a score of 4 or greater in both axillae) when deodorants were not used. When prescreening was not possible, subjects were required to meet pre- treatment odor requirements. They were instructed as follows: 1. Abstain from use of all deodorants, antiperspirants, and perfumed or medicated products in the axillae 7 days before you are scheduled to start the official test, con- tinuing for the entire test period. 2. Abstain from smoking, chewing gum, and use of alcoholic beverages for at least 15 minutes prior to each visit to the test location during the entire test period. 3. Use Ivory soap for all bathing and washing during test periods. This includes: (a) the pretest period prior to the actual test start date and (b) during the test period up
AXILLARY ODOR EVALUATION 285 to its completion. You are also to abstain from all underarm washing during the test period indicated above, except for supervised washing at the test location. 4. Females may shave their underarms on the Sunday just prior to the testing period and abstain from any underarm shaving during the entire test duration. 5. On the day prior to Test Day 1, wash armpits in the morning only with Ivory soap. Do not wash armpits during the day or in the evening. Appear at the test site the next morning without washing. 6. Men are required to put on a clean shirt after each product application each day. Women are required to change into a freshly laundered blouse after each product application each day. B. Deodorant Judge Selection Deodorant judges were selected on the basis of being able to discriminate between several concentrations of isovaleric acid. 1. Isovaleric Acid Standards. The following concentrations of isovaleric acid were pre- pared in dibutyl phthalate: 0, 5, 20, 72, 277, and 600 ppm. A 25-ml aliquot of each was measured into an amber, one ounce bottle with an 8--10 mm orifice. Samples were kept refrigerated until needed but equilibrated at 37øC for 1 hour prior to use for ranking. 2. Rank Ordering. Each candidate judge was given each of the above standards separately to rank. The candidate ranked them on an increasing intensity scale of 0-10 (using even numbers only). The candidates with the highest numbers of correct identification scores were those chosen to judge axillary odor. C. Odor Evaluation-Tube Method 1. Odor evaluations employ a 10~point scoring system. This system is based on a scale of underarm odor from no malodor (0) to moderate malodor (5) to strong, disagreeable odor (10). When fragrances are involved, judges are instructed to disregard them in scoring. Judges should not smoke or eat within 15 minutes prior to odor evaluation, abstain from use of fragrances, and must be present at all evaluations. Evaluations of axillary odor are made by odor judges using the indirect (test tube) method. a. One 20 x 150-mm borosilicate glass test tube is placed in each axillary vault (bottom end in vault) and held in place by the subject by holding the arms close to the body. b. When directed, the subject vigorously rubs the bottom portion of the tube in the axilla and hands the tube to the operator who covers the bottom portion of the tube with a plastic tube closure (KIMKAP ©) and places the tube onto a rack. c. The other axilla is sampled in the same manner. d. When both axillae are sampled, the tubes are quickly passed to two judges who independently evaluate odor clinging to the tubes. © Kimble, Div. Owens-Illinois.
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